Globally, hospital acquired infections pose a major burden to patients. According to the Centers for Disease Control and Prevention (CDC), hospital acquired infections affect about one in twenty-one patients. Accounting for over 250,000 cases annually, catheter-related bloodstream infections (CRBSIs) are one of the most common hospital acquired infections. CRBSIs can lead to bacteremia and septicemia in hospitalized patients. Notably, septicemia, which is a systemic response to the presence of bacteria in the bloodstream, poses a serious health hazard to patients and is associated with a mortality rate of up to 30%. Dealing with the sequelae of bloodstream infections such as septicemia is a major financial burden to the healthcare system and is believed to cost at least $7 billion every year.
The primary source of CRBSIs is thought to be microflora colonization on the catheter hub and subsequent ingress of the microflora into the catheter lumen. Indeed, microflora colonization is believed to account for 54% of all CRBSIs. The catheter hub, the site at which fluids and drugs are injected into the bloodstream, is a common source for infection because it is frequently handled and manipulated by healthcare personnel and in close proximity to a patient's skin and/or clothing as well as the exogenous hospital environment that is often ridden with microbes. Typically, the catheter hub contains a luer connection system.
In an effort to reduce the impact of CRBSIs, the CDC has issued guidelines that describe various ways to minimize bloodstream infection rates in hospital, outpatient, and home care settings. The guidelines provide protocols for hand hygiene, catheter site care, and admixture preparation, that when followed, are expected to reduce the number of CRBSIs. However, despite these CDC guidelines and attempts to educate healthcare personnel on the correct procedure to disinfect the catheter hub and luer connectors, infections continue to plague healthcare systems at relatively unchanged rates. In fact, a gap analysis study identified inadequate catheter maintenance as the main cause of CRBSIs. Specifically, health care providers were not consistently scrubbing the hub with alcohol for the required 15 seconds before accessing the line. Accordingly, there is a need for more robust systems and methods for treating luer connectors that is immune to human error and inconsistencies.
The prior art describes a variety of systems and devices to treat the luer connectors and prevent downstream CRBSIs. One method for preventing downstream CRBSIs utilizes an antibiotic. For example, once a catheter is suspected of infection due to a patient displaying symptoms like inflammation and redness at the site of insertion, first-line therapy with locally administered intraluminal antibiotics such as ethanol or antibiotic lock therapy may be used. While not routinely utilized for the prophylaxis of infections, the guidelines from the Infectious Diseases Society of America encourage the use of antibiotic lock solutions with vancomycin, gentamicin, cefazolin, or ethanol as a therapeutic option for intraluminal infections when the catheter is difficult to remove. The use of an antibiotic lock solution is appealing for localized infections because it is easy to use and associated with low costs and minimal systemic side effects if the catheter remains closed. Generally, antibiotics are recommended in a short-term regimen of 7 to 14 days. The main disadvantage with antibiotic locks is the increased risk of bacterial resistance. Specifically, biofilm-forming species like Staphylococcus have been shown to become resistant to methicillin and vancomycin. Accordingly, there is a need for methods and systems for treating a luer connectors that are prophylactic and do not contribute to bacterial resistance.
Another method for treating the luer connectors and preventing CRBSIs is the use of ethanol caps. For example, 3M™ Curos™ Disinfecting Port Protectors use 70% isopropyl alcohol (IPA). In particular, these port protectors contain 70% IPA that bathes the surface of the luer connector when the luer engages with the port protector. The port protectors disinfect the surface of the luer connector after 1 minute of contact. Notably, the Curos™ Disinfecting Port Protectors can only maintain sterility when the hub is not in use. When the cap is removed to inject fluids or drugs into the catheter, the sterile environment is contaminated.
Similar to the mechanism utilized by 3M™ Curos™ Disinfecting Port Protectors, ICU Medical's SwabCap® also utilizes a 70% IPA solution. In particular, the SwabCap® includes a 70% IPA Sponge that bathes the threads and top connectors of the luer for needlefree connectors on catheters. Additionally, the SwabCap® includes a thread cover design that is configured to disinfect the connector surface and threads of the catheter. Like, 3M™ Curos™ Disinfecting Port Protectors, SwabCap® also fails to disinfect the luer connector when it is in use. For example, incoming bacteria from a syringe or needleless connector cannot be eradicated by the mechanism used by SwabCap®. Moreover, as the SwabCap® only disinfects the top surface of the needle free connector's threads, other portions of the hub such as the intraluminal surfaces remain vulnerable to contamination.
Accordingly, there is a need for methods and systems for treating a luer connector that provide treatment to the luer connector, even while a cap for the catheter hub is removed and/or a syringe, needleless connector or the like is attached to the catheter hub.